MAUDE Adverse Event Report: PHILIPS RESPIRONICS INC PHILIPS DREAMSTATION BIPAP; VENTILATOR, NON-CONTINUOUS (RESPIRATOR)

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problems Sore Throat (2396); Cough (4457)

Event Date 05/15/2020

Event Type  malfunction  

Event Description

Caller has been experiencing persistent cough and sore throat for sometime now due to a faulty device.Caller advised the humidification no longer works and the manufacturer has also issued a recall notice.Caller wants a replacement as he needs the device to sleep.Caller advised the manufacturer has not responded to him and wants the fda to evaluate and find a resolution for him and the other users of the device who need this device to sleep.

• Brand Name: PHILIPS DREAMSTATION BIPAP
• Type of Device: VENTILATOR, NON-CONTINUOUS (RESPIRATOR)
• Manufacturer (Section D): PHILIPS RESPIRONICS INC
• MDR Report Key: 12554596
• MDR Text Key: 274446973
• Report Number: MW5104302
• Device Sequence Number: 1
• Product Code: BZD
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 64 YR